At Immersus Health Co, one of the things I enjoy most as we continue to market the clinically evidenced Immersus and Posture-Mate products with new potential customers, is that I get to meet a lot of fellow Clinicians, Hospice and LTC Administrators, DON’s, Wound Care Nurses and other Clinical Staff. These are dedicated, concerned and caring professionals, who take pride in the care that they provide. But sometimes poor product choices due to lack of clinical evidence can impact the standard of care that they provide.
Aside from needing to prevent and heal pressure injuries, the most frequent concern I hear regards the number of patients who fall on a weekly basis, and what can be done to prevent them, especially at a time when fall alarms and bed rails can no longer be utilized.. Many facilities or agencies may experience “transportable falls” that result in patients with injuries needing an Ambulance, ER visit, and sometimes admission to an acute care facility because of the injuries they sustain.
All of this results in interrupted end of life care for the patient and relatives at a time when every moment counts. Sometimes falls hasten the end of life process, robbing the patient and family of valuable time, and a positive end of life experience. Financially, transportable falls and admissions due to injuries cost the Hospice or LTC facility a lot of money, and shorten the length of time that the patient is in their care, which further impacts revenue. With transparency regarding state fines, audits and injury statistics, falls and wounds can damage the reputation that a care organization has worked hard to grow and maintain.
What used to be considered “safety” devices like fall alarms, raised mattress perimeters, geriatric recliners and bed side rails are now deemed to be “patient restraints” and are no longer allowed. Statistically, falls are one of the main reasons for hospital readmissions, which creates a challenge as to how you can successfully protect your patients and your facility from falls and wounds, and be sure that you are not breaking any rules, or taking false measures that may not work?
Class 1 Medical Devices:
With any medication or medical equipment that has a specific effect on a patient, clinical evidence in the form of patient trials that validate clinical efficacy and positive patient outcomes is required, otherwise these treatments and products could not be marketed safely.
Mattresses and seat/back cushions are Class I medical devices. A Class I medical device is any device that has a low to moderate risk to the patient and/or user. In the USA, 47% of medical devices fall under this category with 95% of these being exempt from the FDA 510K, pre-market approval regulatory process.§ Unfortunately, following the FDA Modernization Act of 1997, if a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA 510K, pre-market clearance is not required before marketing the device. However, the manufacturer is required to register their establishment and list their product with FDA. This means that anyone can manufacture and market a mattress or seat cushion without necessarily validating its effectiveness for comfort, fall prevention, pressure injury prevention or wound healing.
Because of this, much of the product available for equipment providers and Hospices and LTC facilities to choose from is not always appropriately designed or tested for specifically for elderly and end of life patients. Product choices are confusing, and there is a plethora of product that purports to be clinically effective, without having any clinical evidence.
Choosing Clinically Proven Products:
So how can you successfully navigate the minefield of potential poor product decisions, and ensure that you are making good product selections that will support fall and wound reduction effectively?
The answer is to select products that have been designed specifically for elderly and end-of-life patients, that also have “true Clinical evidence.” “White Papers”, because they are often corporately produced often read as marketing pieces instead of “true Clinical evidence.” True Clinical Evidence in the form of real-life multi-patient clinical outcome studies, will be published in reputable peer reviewed medical journals.
This is exactly what we have done at the Immersus Health Company. We took the high road, and ignored the fact that there is FDA product exemption for Mattresses and Seating products. We want Hospices and LTC facilities to be able to be able to make an informed choice about our product and rest assured that it is the best possible selection for wound and fall prevention. Through a real-life multi-patient clinical study, we have proven that our product designs really work clinically in terms of, quality, safety, patient and user satisfaction and clinical performance for preventing wounds and falls. By doing this, we have shown irrefutable clinical evidence that our products really do support a fall prevention program, while also preventing pressure injury formation, promoting wound healing, greater patient comfort, pain reduction and increased patient satisfaction an compliance. The clinical results speak for themselves, and are the assurance that you are making a sound product selection decision.
Customers who have implemented this method of validating their product selection have found that their incidence of falls has significantly reduced, and that the prevalence of pressure injuries is much less widespread…in fact many times, facilities can avoid expensive adjunctive therapies for healing pressure injuries, because they are successfully avoiding them to begin with.
Doing the right thing:
You would not choose inferior treatments or medications for your patients that have not been validated clinically, so why risk patient safety and skin integrity by choosing non-clinically validated mattresses and seat cushions? Raise your standard of care and optimize your patient outcomes with evidence-based fall and wound prevention solutions.
Please click on the clinical tab to read the full published multi-patient clinical outcome study.
James Hadland
REF: § AHCA
